Evaluation of a Personalised Survivorship Care Plan App for Patients With Melanoma (Melanoma SCP)

June 6, 2025 updated by: Marjolein Lugtenberg, Erasmus Medical Center

Personalised Survivorship Care for Patients With Melanoma: A Multicenter Randomised Controlled Trial of the Survivorship Care Plan App

A multicentre randomised controlled trial (RCT) will be conducted to evaluate the effectiveness of the digital personalised Melanoma Survivorship Care Plan (SCP) app. A total of hundred-eighty melanoma patients (stage I and II) will be randomised to receive either the SCP Melanoma app or usual care. The app provides survivors with personalized healthcare information on diagnosis, treatment and follow-up and supportive care, tailored to their melanoma stage and phase and information needs.Through questionnaires, medical file records, patient-reported outcomes and use of medical care will be evaluated. In addition, log-data, questionnaires and interviews will be used to evaluate the process of the uptake and implementation of the digital SCP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The growing and diverse group of survivors of stage I and II melanoma leads to an increasing need for patient-tailored survivorship care. To meet these needs, the Survivorship Care Plan (SCP) app ('Digizorg Melanoma app') was developed together with patients and healthcare providers, providing patients with melanoma with personalised information on diagnosis, treatment and follow-up and supportive care. The aim of this study is to evaluate the effectiveness of the Digizorg Melanoma SCP app in terms of patient and provider-reported outcomes and clinical practice.

A multicenter randomized controlled trial (RCT) will be performed in four Dutch hospitals, namely Erasmus MC, Albert Schweitzer hospital, Maasstad hospital and Franciscus Gasthuis & Vlietland. A total of 180 patients (stage I and II) will be randomized to receive either the 'SCP-app' or 'usual care'. Patients are included within 0-4 months of primary diagnosis. If patients are diagnosed with stage III or IV, they are excluded. The app consists of information tailored to survivors' melanoma stage and phase as well as their information needs. Participants receive questionnaires at baseline, and at 6 and 12 months. Additionally, medical records are examined for healthcare use. The primary outcome is patient empowerment. Secondary outcomes are satisfaction with information and care, fear of (return of) cancer, needs for supportive care, coping style and healthcare use. Additionally, a process evaluation will be conducted to gain insight into the uptake and evaluation of (the implementation of) the intervention by users.

To evaluate the effectiveness of the Digizorg Melanoma app (effect evaluation), scores on outcome measures will be compared between the two study groups through questionnaires and medical file records analysis, correcting for baseline scores. The primary outcome measure is patient empowerment. Secondary outcome measures are medical care consumption, costs, fear of (return of) cancer, need for supportive care, coping style and satisfaction with information and care. All outcome measures are measured in both groups in the form of questionnaires at the start of the trial (T0) and 6 (T1) and 12 months (T2) after inclusion. Medical file records (number of healthare appointment records in the file) will only be assessed at the start of the trial (T0) and after 12 months (T2).

To gain insight into the uptake and evaluation of (the implementation of) the intervention (process evaluation), (log) data on the use of the app will be analysed, short satisfaction questionnaires will be administered twice to patients and up to 30 short-term interviews with patients and other stakeholders (including healthcare providers, IT specialists and developers) will be conducted to explore satisfaction with app, impact on coordination and suggestions for improvement.

There are no specific risks associated with participating in this study. Participants will have the opportunity to use the app with personalised information on diagnosis, treatment and follow-up and supportive care. However, no specific actions are imposed and the care participants receive remains the same. Participation in the study does require a time investment from patients in the form of completing questionnaires three times over a year. However, the time investment will be limited to 30-45 minutes each time. In addition, the number of questions that can be perceived as burdensome by patients is limited. A small proportion of patients will additionally be approached for a short-term interview (of max 30 min) as part of the process evaluation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Zuid-Holland
      • Dordrecht, Zuid-Holland, Netherlands, 3318 AT
        • Recruiting
        • Albert Schweitzer Hospital
        • Contact:
        • Principal Investigator:
          • Peter Plaisier, PhD
      • Rotterdam, Zuid-Holland, Netherlands, 3015GD
        • Recruiting
        • Erasmus MC
        • Contact:
        • Principal Investigator:
          • Marjolein Lugtenberg, PhD
      • Rotterdam, Zuid-Holland, Netherlands, 3079 DZ
      • Rotterdam, Zuid-Holland, Netherlands, 3045 PM
        • Not yet recruiting
        • Franciscus Gasthuis & Vlietland hospital
        • Contact:
        • Principal Investigator:
          • Frederique Beverdam, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years or older
  • Patients who have received a primary diagnosis of cutaneous melanoma stage I to II in the past 0-4 months

Exclusion Criteria:

  • Patients with irresectable stage III melanoma, patients receiving neo-adjuvant treatment and patients with stage IV melanoma.
  • Patients who do not have (sufficient) command of the Dutch language.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Participants receive access to the Digizorg Melanoma app, on top of care as usual.
Device: Digizorg Melanoma app
The Digizorg Melanoma app is a digital survivorship care plan, in which ellaborated information regarding diagnosis, treatment and follow-up and supportive care, adjusted to one's personal preferences and disease characteristics, is offered in the form of a mobile application.
No Intervention: Control group
Participants have access to care as usual, but have no access to the Digizorg Melanoma app and its functionalities.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient empowerment
Time Frame: 1 year after inclusion
The extent to which patients are able to cope with their own condition. This is a result of understanding by the patient of his/her role, acquisition by patients of sufficient knowledge to be able to engage with their healthcare provider, the skills of the patient skills and the presence of a facilitating environment. This outcome is measured through a scaled questionnaire (Health Education Impact Questionnaire), on which higher scores indicate a more health-conscious, self-monitored and empowered self.
1 year after inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Medical care consumption
Time Frame: 1 year after inclusion
The amount of (additional) contact moments (including telephone consultations) with medical specialists, nursing specialists and assistant physicians in the hospital, on top of care as usual.This outcome is measured in volumina through a questionnaire (iMTA Medical Consumption Questionnaire) and medical file research.
1 year after inclusion
Costs
Time Frame: 1 year after inclusion
All medical costs, related to healthcare utilization, and non-medical costs, related to productivity loss and implementation of the application. This outcome is calculated through the volumes of medical care consumption and productivity loss.
1 year after inclusion
Satisfaction with care
Time Frame: 1 year after inclusion
Overall subjective assessment of the received care around melanoma. This outcome is measured through one scaled question of a questionnaire (EORTC Outpatient satisfaction 7-items), of which lower scores indicate less satisfaction with care.
1 year after inclusion
Fear of recurrence
Time Frame: 1 year after inclusion
The extent of worries and fears surrounding cancer in oncology patients. This outcome is measured through a questionnaire (Cancer Worry Scale). Higher scores indicate more distress around cancer recurrences.
1 year after inclusion
Coping style
Time Frame: At baseline
The thoughts and behaviors mobilized to manage internal and external stressful situations. This outcome is measured through a questionnaire (shortened Threatening Medical Situations Inventory), in which two hypothetical situations and resulting actions are assessed and scored.
At baseline
Productivity loss
Time Frame: 1 year after inclusion
The extent to which the person's ability to perform his/her work is affected as a result of the disease. This outcome is measured in volumina through a questionnaire (iMTA productivity cost questionnaire).
1 year after inclusion
Satisfaction with information
Time Frame: 1 year after inclusion
The extent and quality to which patients feel informed, specifically during treatment for melanoma. This outcome is measured through a questionnaire (EORT Core Quality of Life Questionnaire Information module 25-items), by which self-report can express high satisfaction with information (high scores) to low satisfaction (low scores).
1 year after inclusion
Need for supportive care
Time Frame: 1 year after inclusion
The individual needs of the patient for care, upon which targeted supportive care can then be provided. This outcome is measured through a questionnaire (Supportive Care Needs Survey - Short form 34-items), exposing different areas for needs through distinguishment of the level of satisfaction and need for care.
1 year after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Albert Schweitzer Hospital
Franciscus Gasthuis
Maasstad Hospital
BeterKeten

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10147 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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